PathoProbes & PathoWAND

Patho Care – a -point-of-care-testing system for COVID-19 and other respiratory diseases with real-time results at 97% accuracy – may save tens of thousands of lives.

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Check out PathoProbes & PathoWAND on @MedStartr Today Patho Care – a -point-of-care-testing system for COVID-19 and other respiratory diseases with real-time results at 97% accuracy – may save tens of thousands of lives. #MedMo #MedStartrVentures

https://www.medstartr.ai/s/0y6IvEkkkcc

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Clinical Validation

Phase 1 thru 3 Clinical Trials should be performed. Phase 1 trials are to prove the efficacy and safety of the POCT devices in the testing of human subjects infected with microorganisms such as COVID-19.  Phase 2 involves small human trials (<250 subjects).  Phase 3 is a full human trial (3000+ subjects) to establish statistical accuracy of the POCT devices which should lead to FDA approval. The POCT device trials will have a wide range of participant subjects (men, women, and children of all ages, races, and ethnic groups).  The sequence for the Programmable Pathogen Test Unit (PPTU) is as follows: Clinical Trial Milestones – Projected Duration of 16 Months <ol> <li>PPTU Safety Validation</li> <li>PPTU Efficacy</li> <li>PMA (Pre-Market Approval) & EUA (Emergency Use Authorization) Approved</li> <li>Phase 1 Clinical Trials Complete</li> <li>Phase 2 Clinical Trials Complete</li> <li>Phase 3 Clinical Trials Complete</li> <li>FDA Certification</li> </ol> Using traditional projections, the cost for the first year is projected to be $6,000,000, essentially through Phase 1.  I may double in the second year.  The PathoProbes and PathoWAND are believed to qualify for application for “Emergency Use Authorization” (EUA) under Section 564 of the Food, Drug and Cosmetics Act (FD&C Act), 21 U.S.C. §360bbb-3.  As indicated above, Patho Care hopes to apply for EUA after safety and efficacy have been established, perhaps after 6 months.  In addition, Patho Care hopes to be above to file and application for "Premarket Approval" (PMA) (a) pursuant to FD&C Act §§515 and 515A, 21 U.S.C. §360e.

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